Mylan’s proposed ANDA drug does not infringe MedCo patents

The Meds. Co. v. Mylan, Inc.,  (Fed. Cir. Apr. 6, 2017) (Before Dyk, Wallach, Hughes, J.).

The Medicines Company (“MedCo”) sued Mylan, Inc. (“Mylan”) alleging infringement of two patents (the ’727 patent and the ’343 patent) after Mylan submitted an Abbreviated New Drug Application (“ANDA”).  Mylan counterclaimed, seeking a declaration that the patents were invalid. The patents are directed to pharmaceutical formulations, or “batches,” of the drug bivalirudin, which is used to prevent blood clotting in patients undergoing cardiac catheterization. The goal of both patents is to achieve “batch consistency,” or a consistently low level of impurities in each batch of bivalirudin. The issue at the district court and on appeal is whether the claims of the ’727 and ’343 patent require batch consistency to be accomplished through an “efficient mixing” process.

On summary judgment, the district court found that the ’343 patent required an “efficient mixing” process and that Mylan did not infringe the asserted claims.  Following a bench trial, the district court found that the ’727 patent did not require “efficient mixing” and that Mylan did infringe the asserted claims. The court rejected Mylan’s invalidity contentions.

On appeal the Court first addressed whether the ’727 and the ’343 patents require “efficient mixing” to achieve batch consistency. Based on the specification and the prosecution history, the Court found that the specific process claimed by the ’727 and ’343 patents to achieve batch consistency is “efficient mixing,” which consistently produces batches having lower level of impurities than other, unclaimed mixing processes. The Court concluded that the ’727 and ’343 patents “teach[] efficient mixing as a necessary and sufficient condition for achieving batch consistency.” As a result, both the ’727 and the ’343 patents require an “efficient mixing” process, which the Court went on to construe. The only mention of “efficient mixing” was in Example 5, which distinguished a non-efficient mixing process. Even though Example 5 was “non-limiting,” the Court found that “efficient mixing” was limited to the process in Example 5, because no other portion of the specifications adequately disclosed “efficient mixing.”

The “net effect” of the Court’s claim construction was that “to infringe either the ’727 patent or the ’343 patent, infringing batches must be compounded using a process that employs the efficient mixing conditions of Example 5,” i.e., an “efficient mixing” process. Because it was undisputed that Mylan’s proposed drug did not use an “efficient mixing” process, Mylan did not infringe the ’727 and ’343 patents. The Court reversed the district court’s infringement judgment for the ’727 patent and affirmed the non-infringement judgment for the ’343 patent. The Court did not address Mylan’s invalidity contentions because Mylan agreed that a finding of non-infringement would render its invalidity claims moot.

A claim term can be limited to an embodiment described in the specification, if the claim would otherwise be found invalid and the embodiment was not disclaimed. Thus, a claim term with no ordinary meaning can be defined according to a single example in the specification, if the example provides “a clear objective standard” for that term. 

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